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Contact Information:

Prof Brian Davidson
+44 (0)208 0168 096
b.davidson@ucl.ac.uk


Dr Kellie Platt
+44 (0)151 794 8897
lappie@liverpool.ac.uk


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Be Part of Research - Trial Details - Investigating the feasibility of a clinical trial to test using irreversible electroporation to treat locally advanced pancreatic cancer following initial chemotherapy
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Investigating the feasibility of a clinical trial to test using irreversible electroporation to treat locally advanced pancreatic cancer following initial chemotherapy

Not Recruiting

Open to: All Genders

Age: Adult

Leeds Birmingham Liverpool Wirral London London Newcastle-upon Tyne

Medical Conditions

Malignant neoplasm of pancreas, locally advanced pancreas cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Surgery (pancreatic resection) is the only treatment with the potential to cure pancreatic cancer. Only 10 to 20 out of every 100 people are eligible for surgery. One of the major reasons is that the cancer has spread into the surrounding structures, which is known as locally advanced pancreatic cancer (LAPC). Currently, the recommended treatment for LAPC is chemotherapy (drugs which destroy cancer). Those in whom the chemotherapy prevents the growth or spread of cancer have a chance of improved survival.
Irreversible electroporation (IRE) is a new method of treating cancer. IRE treatment destroys cancer cells by electricity. Under general anaesthetic, IRE probes, which are similar to needles, are inserted into the pancreas and an electrical charge is passed through the cancer.
Early studies in pancreas cancer suggest that IRE treatment may increase how long people with LAPC live. However, there has been no trial to provide evidence of how effective IRE treatment is in people with LAPC that is unsuitable for surgery.
This study aims to find out how feasible it would be to carry out a trial of IRE treatment following initial chemotherapy for LAPC.
The study will also investigate the safety, practicality, and technical success of IRE treatment, how acceptable IRE treatment is to patients and their doctors, how many participants are recruited and withdraw from the study, participant survival, and participant quality of life.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Mar 2024 30 Nov 2024

Publications

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35551086/ (added 16/05/2022)

Following first-line chemotherapy with Folfirinox, participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). One group will receive the IRE procedure followed by standard-of-care chemotherapy, and the other group will receive standard-of-care chemotherapy alone. Patients will be followed up every 3 months for 12 months where they will undergo blood tests and CT scans.


Adults with locally advanced pancreatic cancer who are not suitable for surgical resection

You can take part if:



You may not be able to take part if:


1. First line chemotherapy other than FOLFIRINOX2. Concomitant malignancy (except skin and prostate cancers)3. Metastatic disease including distant (i.e. non-local) nodal metastases4. Borderline resectable disease 5. Occlusion or >180° involvement of the portal vein (superior mesenteric vein/portal vein)6. Arterial involvement with <180° of the superior mesenteric artery, celiac axis, or common hepatic artery 7. Untreated gastric outlet or biliary obstruction8. Co-morbidity precluding general anaesthesia9. Indwelling electrical devices such as pacemakers and Left Ventricular Assist Devices (LVADs)10. Chronic Kidney Disease stage 3, 4, or 511. History of epilepsy or other neurological diseases12. Abdominal varices preventing safe access to pancreas cancer13. Unable to tolerate general anaesthetic with neuromuscular blockade14. Subjects who are actively bleeding, anticoagulation which cannot be discontinued, coagulopathy defined as an international normalized ratio (INR) of ≥1.5, or have any one of the following haematology results: 14.1. Haemoglobin <8 g/dl14.2. Absolute neutrophil count <1500 cells/ml14.3. Platelet count <50,000.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Clatterbridge Road Bebington
    Wirral
    CH63 4JY
  • King's College Hospital NHS Foundation Trust
    King's College Hospital Denmark Hill
    London
    SE5 9RS
  • Royal Free London NHS Foundation Trust
    Royal Free Hospital Pond Street
    London
    NW3 2QG
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Freeman Hospital Freeman Road High Heaton
    Newcastle-upon Tyne
    NE7 7DN

The aim of IRE for LAPC is to provide an improvement in life expectancy and a better quality of life. There is data to suggest this may be effective but it has not yet been proven.
Risks associated with IRE that may rarely occur in a small number of participants include: pain at the treatment site; acute pancreatitis; local vascular occlusion from thrombosis; leakage of fluid from the pancreas, bile duct or duodenum at the insertion point of the IRE probes; and cardiac arrhythmias.

Prof Brian Davidson
+44 (0)208 0168 096
b.davidson@ucl.ac.uk


Dr Kellie Platt
+44 (0)151 794 8897
lappie@liverpool.ac.uk



The study is sponsored by Royal Free London NHS Foundation Trust and funded by National Institute for Health Research.



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Read full details for Trial ID: ISRCTN14986389

Or CPMS 46763

Last updated 25 March 2025

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